Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06125652
Status:
RECRUITING
Last Update Posted:
2023-11-09
First Post:
2023-11-04
Brief Title:
Administration of Anti Tim-3CD123 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia rrAML
Sponsor:
Xuzhou Medical University
Organization:
Xuzhou Medical University
Study Overview
Official Title:
Application of Anti Tim-3CD123 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia rrAML
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the safety and efficacy of anti Tim3CD123 CAR-T cells in the treatment of relapsed and refractory acute myeloid leukemia
Detailed Description:
Cluster of Differentiation 123 CD123 is usually overexpressed on leukemia stem cells LSCs in acute myeloid leukemia AML However CD123 has poor specificity and is also expressed on normal hematopoietic stem cells HSC myeloid cells and some non-hematopoietic cells This leads to widespread on-target off-tumor effect in the clinical application of anti CD123 CAR-T cells manifested as severe bone marrow suppression organ damage and patients experiencing infections bleeding and organ dysfunction T cell immunoglobulin and mucin domain 3 Tim-3 belongs to the Tim gene family 85 of LSCs highly express Tim-3 while normal hematopoietic stemprogenitor cells HSCP granulocytes and macrophages do not express Tim-3 Compared with CD123 seeing Tim-3 as a recognition tool for LSCs has higher specificity In vivo and in vitro studies have confirmed that anti Tim-3 CAR-T cells have significant anti LSCs effects while not affecting the ability of normal HSCP to form colonies and differentiate lineages We believe that using both Tim-3 and CD123 as targets for CAR-T cells can improve the specificity of recognizing LSCs reduce the killing effect of CAR-T cells on HSCP expressing CD123 and thus reduce the on-target off-tumor effect
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None